OTC - WHEN USING SECTION
WARNINGS: For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
WARNINGS: For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if rash occurs
Keep out of reach of children. if product is swallowed get medical help or contact a Poison Control center right away
ACTIVE INGREDIENTS: TITANIUM DIOXIDE 15.0%, ZINC OXIDE 10.0%
PURPOSE: SUNSCREEN
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 31645-159-02 | 2020-01-30 | C162847 | 48780-1 | 97449f38-bb19-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 31645-159-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bb19-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| Asian Ginseng | INACTIVE INGREDIENT | CUQ3A77YXI | 1 | |
| Chamomile | INACTIVE INGREDIENT | FGL3685T2X | 1 | |
| Chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| Ferric Oxide Black | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| Ginkgo | INACTIVE INGREDIENT | 19FUJ2C58T | 1 | |
| Magnesium Silicate | INACTIVE INGREDIENT | 9B9691B2N9 | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Safflower Oil | INACTIVE INGREDIENT | 65UEH262IS | 1 | |
| Sodium Dehydroacetate | INACTIVE INGREDIENT | 8W46YN971G | 1 | |
| Tricaprylin | INACTIVE INGREDIENT | 6P92858988 | 1 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 | |
| Zinc Stearate | INACTIVE INGREDIENT | H92E6QA4FV | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 31645-159 | 31645-159-01, 31645-159-02 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, FILM COATED / ORAL | 33.7 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | SUPPOSITORY / RECTAL | 16 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET / ORAL | 72 mg | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | CAPSULE / ORAL | 40 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, COATED / ORAL | NA | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| Tricaprylin | TRICAPRILIN | 6P92858988 | INJECTABLE, LIPOSOMAL / INFILTRATION | 0.2 %w/v | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE, DL- | .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | AEROSOL, FOAM / TOPICAL | NA | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET / SUBLINGUAL | 2.5 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET / ORAL | 10 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SPRAY, METERED / NASAL | 0.06 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | CAPSULE / ORAL | 2.04 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| Ferric Oxide Black | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | WAFER / ORAL | 22 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, COATED / ORAL | 29.03 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | LOTION / TOPICAL | 0.2 %w/w | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | AEROSOL, FOAM / TOPICAL | 8 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET, FILM COATED / ORAL | 15.2 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 60b6bc89-53bd-4678-8ff1-e4019be8a477 | f3f99d45-afac-4f60-9138-6a156cab233a | 2011-11-29 | 60b6bc89-53bd-4678-8ff1-e4019be8a477 f3f99d45-afac-4f60-9138-6a156cab233a |
Adverse event summaries are temporarily unavailable. Other product information remains available.